0 Novo Nordisk A/S Global Niche Pharma with Biotech Expertise Fall 2000
1 Demerger process update Health Care Enzymes Detailed historic financial data Demerger Document, October 2000 Demerger Document and Prospectus, October 2000 Road shows Aug./Sept November 2000 Extraordinary Gen. Meeting November 13, 2000 Pure Play Listing Nov./Dec. 2000
2 Chief Science OfficerMadsKrogsgaardThomsen Novo Nordisk A/S Executive Committee (post-demerger) Chief of Staffs and Quality KåreSchultz Chief Financial OfficerJesperBrandgaard Chief Operating Officer Lars Almblom Jørgensen President & CEO Lars Rebien Sørensen
3 CSOS&QCFO COO CEO Novo Nordisk A/S Executive Committee (post-demerger)
4 A global niche pharma company Leadership position in diabetes care Strong market presence in haematology and growth disorders World class pipeline in key therapeutic areas Proven, genuine biotech expertise in R&D and access to ZymoGenetics Drug delivery technology platform Outstanding presence in Europe and Japan US growth platform Strong sales growth, significant cash flow generation, robust balance sheet.
5 Diabetes Care business Growth Disorders ZymoGenetics HRT Novo Nordisk – Key drivers Primary growth drivers Secondary value drivers NovoSeven® business
6 Our ambition Continue to be the world’s leading diabetes care company Offer products and services in other areas where we can make a difference Grow our product pipeline through internal and external sourcing Build upon our biotechnology expertise and link with ZymoGenetics to harness the full potential of the genomics revolution Continue to improve financial performance.
7 Worldwide presence Regional sales distribution 1997 HY 2000
8 Health Care half year 2000 Turnover by therapy % of DKK million total % chg. Insulin and devices etc.6,3215,21765%21% NovoNorm ® /Prandin™ %59% Diabetes Care, Total6,8345,540 70%23% NovoSeven®1, %84% Growth Disorders %20% HRT %8% Other %11% Health Care, Total9,6697, %26%
9 Diabetes Care
10 % of DKK million total % chg. Insulin and devices etc.6,3215,21765%21% NovoNorm ® /Prandin™ %59% Diabetes Care, Total6,8345,540 70%23% NovoSeven®1, %84% Growth Disorders %20% HRT %8% Other %11% Health Care, Total9,6697, %26% Health Care half year 2000 Turnover by therapy
11 Insulin market overview Novo Nordisk Market share (‘00) Market growth (‘00/’99) Source: IMS MAT Q volumes. Industrialised world only.
12 Insulin sales growth outlook 10% growth per year Excluding pulmonary What will drive growth?
13 Insulin sales growth drivers 1: Increased number of diabetics Increase in the number of diabetics from 150 million to 220 million – 10 years from now – yearly growth of 3.9%. Source: Amos A.., McCarty DJ, Zimmet P: Diabet. Med. 1997; 14
14 Insulin sales growth drivers 2: Increased rate of diagnosis Only about one third of diabetics are diagnosed Increased rate of diagnosis leads to higher insulin sales.
15 Number of diabetics using medication: million More patients should move to the use of insulin. Oral products Oral/insulin Insulin 66% 7% 27% Insulin sales growth drivers 3: More patients should use insulin
16 The major land mark study, UKPDS *), prescribed: Early intervention Intensified therapy Use products in combination More patients on insulin. *) UKPDS = UK Prospective Diabetes Study Insulin sales growth drivers 4: More intensive therapy
17 Pen penetration for insulin administration Source: IMS MAT Q volumes, Industrial world only. Insulin sales growth drivers 5: Increased product sophistication
18 The industry’s most comprehensive insulin device portfolio One new device to be introduced per year. Conventional syringes Insulin pens Electronic insulin dosers Insulin sales growth drivers 5: Increased product sophistication
19 The industry’s most comprehensive portfolio of insulin analogues Rapid acting insulin analogue launched in EU, approved in US Basal insulin analogue in phase 3 Premixed insulin analogue approved in EU. Insulin sales growth drivers 5: Increased product sophistication
20 The competitive scene Insulin analogues NVO LLY AVE Rapid-acting MarketedMarketedPh1/Ph2 Basal Ph3Marketed Premix, protracted ApprovedMarketed Pulmonary insulin NVO LLY AVE Human short-acting Ph2 Ph2 Ph3 Insulin sophistication
new sales reps. hired / rented during 2000 Total number of reps. by end 2004 = up to 1,000 US insulin market size = USD 1 billion Novo Nordisk market share = 22% (vol.) Pen penetration = 5.7% (vol.) 50% price premium on pen products US market share 21.2% in ’98, 21.5% in ’99 and 22.0% MAT Q Insulin sales growth drivers 6: More aggressive US strategy
22 Health Care half year 2000 Turnover by therapy % of DKK million total % chg. Insulin and devices etc.6,3215,21765%21% NovoNorm ® /Prandin™ %59% Diabetes Care, Total6,8345,540 70%23% NovoSeven®1, %84% Growth Disorders %20% HRT %8% Other %11% Health Care, Total9,6697, %26%
23 NovoNorm /Prandin as gateway to oral diabetes market Oral diabetes market worldwide = $3 billion and growing ~ 20% yearly Type 2 programmes: NN2344: 1st generation sensitiser NN622: Dual acting sensitiser working on glucose and lipids NN4201: Reducing glucose output from the liver NN2211: GLP-1 analogue.
24 Diabetes Care growth drivers Increased number of diabetics Higher diagnosis rate More patients should use insulin More intensive therapy Increased device penetration Conversion to analogues More aggressive US strategy New Type 2 products in pipeline.
25 Diabetes Care R&D Muscle/Fat - Insulin sensitisers - Insulin - Insulin mimetics - PPAR - GLUT4 - TNF - PTPase. Gut - GLP-1. ß -cell - PGR - PCO - GLP-1. Brain - GLP-1. Liver - Hepatic enzyme inh. - PPAR - Glukokinase - Glucagon antagonists - Insulin - Insulin mimetics.
26 Development pipeline Phase 1 Phase 2 Phase 3 Registration NN622 (Dual acting insulin sensitiser) NN2211 (GLP-1) NN1215 (LABI) NN1998 (AERx) NN4201 (Hepatic glucose regulator) NN703 (Growth hormone secretagogue) NN304 (Basal analogue) ® NovoRapid ® (Rapid analogue) ® NovoMix ® (Premix analogue) NN007 (up to 4 new within a year) NN007 (Liver) NN2344 (Insulin sensitiser) NN5492 (Infertility)
27 ® NovoSeven ®
28 ® NovoSeven ® strategy ®Develop NovoSeven ® to become the first general haemostatic agent Develop a range of new clinical indications, new products and new formulations Expansion of production and sales force capacity Price per mg to be kept unchanged Clinical Phase 2 trials on up to four new indications will be initiated within the next year. 28
29 Health Care half year 2000 Turnover by therapy % of DKK million total % chg. Insulin and devices etc.6,3215,21765%21% NovoNorm ® /Prandin™ %59% Diabetes Care, Total6,8345,540 70%23% NovoSeven®1, %84% Growth Disorders %20% HRT %8% Other %11% Health Care, Total9,6697, %26%
30 NovoSeven ® sales growth outlook What will drive growth?
31 NovoSeven ® sales growth drivers 1: Existing haemophilia indication 1999 sales = DKK 1.3 billion ~ USD 165 million Peak sales potential = USD 300 million Launch in Japan 11 May 2000 NovoSeven® Market segmentation for bleedings Coagulation Factor Deficiency Haemophilia with inhibitors
32 NovoSeven ® sales growth drivers 2: Liver indication in Phase 3 Peak sales potential = USD million # of patients = 1.7 million liver patients with coagulopathy # of spontaneous upper GI bleeds = 170,000 # of orthotopic liver transplantations = 8,000 # of other invasive procedures = 600,000 NovoSeven® Market segmentation for bleedings Coagulation Factor Deficiency Haemophilia with inhibitors Liver disease Expansion into liver segment Liver transplantation programme ongoing Further studies for liver patients to be initiated: Upper GI bleeds Liver resection Liver transplantation programme ongoing Further studies for liver patients to be initiated: Upper GI bleeds Liver resection
33 A range of potential indications have been identified and analysed Our strategy for expansion into the Platelet disorder and general general haemostasis area is now in place NovoSeven® Market segmentation for bleedings Coagulation Factor Deficiency Platelet DisorderGeneral Haemostasis Haemophilia with inhibitors Liver disease NovoSeven ® sales growth drivers 3: New expansion strategy
34 Development pipeline Phase 1 Phase 2 Phase 3 Registration NN622 (Dual acting insulin sensitiser) NN2211 (GLP-1) NN1215 (LABI) NN1998 (AERx) NN4201 (Hepatic glucose regulator) NN703 (Growth hormone secretagogue) NN304 (Basal analogue) ® NovoRapid ® (Rapid analogue) ® NovoMix ® (Premix analogue) NN007 (up to 4 new within a year) NN007 (Liver) NN2344 (Insulin sensitiser) NN5492 (Infertility)
35 Coagulation Factor Deficiency Platelet Disorder General Haemostasis Single FactorMultipleFactorsSurgicalbleedingSpontaneousbleeding Lack of PlateletsDefectivePlatelets NovoSeven Market segmentation for bleeding s Haemophilia with inhibitors Liver DiseaseLiver disease Vitamin K- antagonists Vitamin K-antagonists Reversal of oral anti-coagulant therapy Estimated no. of potential targeted severe bleeding episodes per year: 600,000 Vitamin K-antagonists Reversal of oral anti-coagulant therapy Estimated no. of potential targeted severe bleeding episodes per year: 600,000
36 Coagulation Factor Deficiency Platelet Disorder General Haemostasis Single FactorMultipleFactorsSurgicalbleedingSpontaneousbleeding Lack of PlateletsDefectivePlatelets NovoSeven Market segmentation for bleeding s Haemophilia with inhibitors Liver DiseaseLiver disease Vitamin K- antagonists Bone marrow transplantation Estimated no. of potential targeted severe bleeding episodes per year: 13,000 Bone marrow transplantation Estimated no. of potential targeted severe bleeding episodes per year: 13,000
37 Coagulation Factor Deficiency Platelet Disorder General Haemostasis Single FactorMultipleFactorsSurgicalbleedingSpontaneousbleeding Lack of PlateletsDefectivePlatelets NovoSeven Market segmentation for bleeding s Haemophilia with inhibitors Liver DiseaseLiver diseaseIntra-cerebral bleeds Vitamin K- antagonists Bone marrow transplantation Intra-cerebral bleeds 20-30% of strokes are intra-cerebral bleeds Estimated no. of potential targeted severe bleeding episodes per year: 200,000 Intra-cerebral bleeds 20-30% of strokes are intra-cerebral bleeds Estimated no. of potential targeted severe bleeding episodes per year: 200,000
38 Coagulation Factor Deficiency Platelet Disorder General Haemostasis Single FactorMultipleFactorsSurgicalbleedingSpontaneousbleeding Lack of PlateletsDefectivePlatelets NovoSeven Market segmentation for bleeding s Haemophilia with inhibitors Liver DiseaseLiver diseaseIntra-cerebral bleeds Vitamin K- antagonists Bone marrow transplantation Traumatology/ traffic accidents Estimated no. of potential targeted severe bleeding episodes per year: 100, ,000 Traumatology / traffic accidents Estimated no. of potential targeted severe bleeding episodes per year: 100, ,000
39 Coagulation Factor Deficiency Platelet Disorder General Haemostasis Single FactorMultipleFactorsSurgicalbleedingSpontaneousbleeding Lack of PlateletsDefectivePlatelets NovoSeven Market segmentation for bleeding s Haemophilia with inhibitors Liver DiseaseLiver diseaseIntra-cerebral bleeds Traumatology/ traffic accidents Vitamin K- antagonists Bone marrow transplantation Hip replacements Haemorrhagic dilution coagulopathy Oozing after cardiac valve replacement Colon Cancer surgery Gunshot wounds Upper gastro- intestinal Glanzmann Bernard-Souliers
40 Profitable organic growth Billion DKKMargin *) 1999 excluding restructuring costs of DKK 350 million
41 Financial results Health Care Net turnover16,42313,647 12,585+20% Operating profit 3,527 2,933 2,440+20% % of sales21.5% 21.5%19.4% Operating profit adjusted *) 3,877 2,9332,440+32% % of sales23.6% 21.5%19.4% EBITDA adjusted *) 4,820 3,9193,315+23% % of sales29.3%28.7%26.3% *) 1999 excluding restructuring costs of DKK 350 million % chg. DKK million
42 Financial results first half year Health Care DKK million % chg. Net turnover9,669 7,674+26% Operating profit 2,271 1,671+36% % of sales 23.5%21.8% EBITDA 2,784 2, % % of sales28.8%27.8%
43 Balance sheet Health Care Capital expenditures1,3621,7671,950 % of sales8.3%12.9%15.5% Fixed assets10,2849,8709,244 % of sales62.6%72.3%73.4% Stocks and trade debtors6,4966,0445,982 % of sales39.6%44.3%47.5% DKK million
44 ZymoGenetics Approximately 275 people, hereof 200 scientists Using bio-informatics to discover novel gene sequences First to file on approx. 15% of US patents filed on “plausible protein therapeutics” from Dec to Aug Pipeline includes preclinical projects in the areas of immunology and oncology No current projects expected to the reach market before Active dialog with accredited biotech investors is taking place.
45 Environmentally sound Socially responsible Economically viable Triple Bottom Line
46 Human Resources Performance culture –Transparent recognition and incentive scheme –Performance linked stock option programme for >300 managers –Development plans and bonus linked appraisal systems for most employees –Preferred employer Customer focus –All employees to meet a person with diabetes this year Globalisation –Growth in number of employees mainly outside Denmark.
47 Global Niche Pharma company with Biotech Expertise
48 NovoSeven® business Peak sales potential for current indication = USD 300 million Peak sales potential for liver indication (Phase 3) = USD million Strategy for entry into the Platelet Disorder & general General Haemostasis areas Phase 2 studies on up to four new indications to be initiated Patent protection until Primary growth drivers World leader 2/3 of business (insulin) growing >10% Steady growth for 76 years The most comprehensive insulin and insulin device portfolio in the industry – one new device per year Expansion strategy in the US Sensitiser and liver programmes NN2211 (GLP-1 analogue). Diabetes business Secondary value drivers Growth Disorders ZymoGenetics HRT Novo Nordisk – Key drivers
49 No major patent expirations % of 1999 sales with patents expiring in Source: Aros Securities Research and Novo Nordisk
50 Forward-looking statements This presentation contains forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of Such forward-looking statements are subject to risk and uncertainties that may cause actual results to differ materially from expectations, including unexpected developments in the international currency exchange and securities markets, government-mandated or market-driven price decreases for Novo Nordisk's products in the company's major markets and the introduction of competing products within Novo Nordisk's core businesses. These and other risks and uncertainties, are further described in reports filed with the US Securities and Exchange Commission (SEC) by Novo Nordisk and readily available to the public, including the company's Form 20-F, which was filed on 2 May In addition to the risk factors described in the company's Form 20-F, the economic situation in Asia, Russia and Latin America could have an adverse impact on unit sales and/or prices, including currency exchange rates, in The total group sales in Asia (excluding Japan), Russia and Latin America were approximately DKK 2 billion in 1999 corresponding to 10% of total group sales.
51 Global Niche Pharma company with Biotech Expertise
52 Appendix
53 Key e-business activities New diabetes professional portal connecting: –NOVOALERT –International Diabetes Monitor –Web-based retinopathy service and much more.... HaemophiliaForum Product specific sites for all key products B2C sales of devices, e-procurement, B2B sales/order, web-based clinical trials Reinventing corporate and affiliate sites Dedicated e-business unit to drive it. Expanding our leadership position to the web
54 InformationInteractionTransaction Intranet Extranet++++ Internet+++++ Networking in Novo Nordisk
55 Long acting / Basal Insulin
56 Haemophilia with inhibitors FVII deficiency Haemophilia A Haemophilia B Liver Disease Vit. K-antagonists Hip replacements Haemorrhagic dilution coagulopathy Oozing after cardiac valve replacement Colon Cancer surgery Astrocytoma surgery Meningeomas surgery Spinal Orthopaedic surgery Arteriovenous malformations Radical prostatectomy Liver disease Bone marrow transplantation Acute Myeloid leukaemia Haemorrhagic Cystitis Blast crisis in leucemia Myelodysplastic Syndrome - HT Invasive procedures in blood cancer Intra-cerebral bleeds Upper gastro intestinal Traumatology/ traffic accidents Gunshot wounds Coagulation Factor Deficiency Platelet Disorder General Haemostasis Single FactorMultipleFactorsSurgicalbleedingSpontaneousbleeding Lack of PlateletsDefectivePlatelets NovoSeven Market segmentation for bleeding s Glanzmann Bernard-Souliers
57 The key impact of NovoSeven is through injury site selective Platelet activation to ensure high local thrombin formation which secures a tight fibrin clot In patients with haemophilia and inhibitors, NovoSeven establish coagulation through bypassing FVIII (NovoSeven ® ) rFVIIa Activation of Platelets without NovoSeven ® Tissue factor - only at site of injury FXa Platelet activation Thrombin activation and burst Local activation of Platelets & clot formation with NovoSeven ®
58 Sources of innovation Novo Nordisk Diabetes Care R&D R&D Projects Molecular diversity & design Protein chemistry since ‘23 Medicinal chemistry since ‘68 Computational chemistry since ‘75 Rational drug design since ‘83 Combinatorial chemistry since ‘93 Trinomics Genomics: Incyte since ´95 Proteomics: CPA since ‘97 Metabonomics since ‘99 Basic research Hagedorn Research Institute Oxford and Steno Diabetes Centres Academic collaborations Consortiums Drug targets & screening Molecular biology since ‘80 HT screening: Amersham since ‘92 Chemoinformatics since ’95 Dundee MRC consortium since ‘98 Ultra HT screening since ‘00 Clinical research Steno Diabetes Centre Oxford Diabetes Centre Clinical research centres worldwide Evidence-based medicine NN disease mgt programmes Outcomes data from > 100,000 individuals with diabetes
HGS ZGI Genentech GI Schering SKB Millennium Immunex Incyte Amgen First Patent Filing Dates on Plausible Therapeutic Proteins: 12/93 to 8/98 Z YMO G ENETICS
60 ZymoGenetics-FibroGen Collaboration Research collaboration signed in July 2000 Focused on advancing the safety and efficacy of tissue sealant products for wound management ZGI to pair its recombinant human thrombin with FibroGen’s recombinant human Type III collagen FibroGen is a private biotech company and leader in recombinant human collagen and gelatin biology.
61 ZymoGenetics – Soluble TACI Research reported in April 27, 2000 issue of Nature Novel immunosuppressive agent with therapeutic potential for systemic lupus erythematosus (SLE) and other autoimmune disorders Modified form of a receptor found on surface of B cells, and member of the TNF receptor family SLE affects over 200K people in the US. No new drug launched for SLE in nearly 40 years Other potential indications include, inter alia, Myasthenia Gravis and Rheumatoid Arthritis.
62 Vision for Novo Nordisk The world’s leading diabetes care company –Our aspiration is to defeat diabetes by finding better methods of diabetes prevention, detection and treatment –We will work actively to promote collaboration between all parties in the health care system in order to achieve our common goals Offer products and services in other areas where we can make a difference –Our research will lead to the discovery of new, innovative products also outside diabetes. We will develop and market such products ourselves whenever we can do it as well as or better than others Competitive business results –Our focus is our strength –We will stay independent and form alliances whenever they serve our business purpose and the cause we stand for
63 Our marketing strategy Working together with patient organisations and health authorities Examples: The Diabetes Foundation in Spain Accredited education courses for GPs in Scandinavia and the UK Web Cafe and Type 2 education programme in France Children education project in Poland
64 Children Education Project Poland Centrally developed education package & 30 participants at the train-the-trainer workshop Managing 9000 children with diabetes 17 Workshops for 239 paediatricians and nurses
65 Triple Bottom Line To obtain trust and license to operate and innovate To attract and retain the most talented people To minimise risks and create possibilities To understand signs from stakeholders To be part of defining new legislation and requirements To meet rising demand from investors (e.g. Dow Jones/ Sustainable Group Index) Why combine business, environment, and stakeholders?
66 Health Care Half Year 2000 Turnover by geography DKK millionHY/00HY/99 % of total % change (HY/00) EU 3,8653, Japan1,9261, USA 1,6811, Rest of World2,1971, Total 9,6697,
67 Group financial results Half Year 2000 Net turnover12,016 9, Operating profit as reported 2,589 1, Operating profit adjusted *) 2,2591, Financial items(25)(150) - Profit before tax2,564 1, Net profit1,615 1, Earnings per share (DKK) Earnings per ADS** ) (USD) * ) Excluding Seroxat® license income and one-off income in HY/00. ** ) Translated for convenience at the end of HY/00 exchange rate of USD 1 = DKK DKK million HY/00 HY/99 % change
68 Enzymes Business Half Year 2000 Financial results Net turnover 2,367 2,182 8 Operating profit Operating margin13.4%11.7% DKK million HY/00 HY/99 % Change